Ageing as a Mindset: A Counterclockwise Experiment to Rejuvenate Older Adults

NCT ID: NCT03552042

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-12-30

Brief Summary

Ageing is generally perceived as a biologically-determined process. There is growing literature, however, that discusses the role of psychological factors in the ageing process. In particular, age-related stereotypes, which reflect the images that people have about the ageing process, seem to have a strong influence on health and life satisfaction, through self-fulfilling prophecy mechanisms. According to the stereotype embodiment theory, mindful changes in these images will promote a change in both the mind and the body, resulting, for example, in a rejuvenation and in a higher quality of life.

The project aims to investigate whether changes in mindsets (i.e., addressing one's age-related stereotypes) can change the ageing process. The psychological components of ageing, as well as how these could be reverted, will be investigated. In other words, the study aims to provide a first answer to the question: "can the mind be used to become younger?" To answer this question, the project will test the efficacy of an intervention labeled "counterclockwise", based on an original, yet un-replicated, pilot study by Ellen Langer, at Harvard. A group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period.

The counterclockwise intervention will be tested against an active control group and a no-treatment group, with a randomized controlled trial. People in the active control group will spend a week in the same location of the counterclockwise intervention, mirroring the same activities, without any kind of time manipulation. Participants in the no-treatment group will only receive the assessment. Ninety participants will be randomly allocated to one of these three groups. Every participant will be assessed for medical, cognitive, psychological, and age appearance, four times: at the recruitment, after the intervention (i.e., after a week for the no-treatment group), and again after 6 and 12 months.

Expected results will be able to promote a mindset-shift not only in the participants but in the general population. The communication plan, which is integrated into the project plan, includes the presentation of the results to communities and associations of older adults, using the experiment as a proof of concept. It will demonstrate that challenging rigid, culturally driven, age-related stereotypes can result in health and well-being improvement. This is expected to lead to a significant improvement of empowerment and perceived control, with the potential to become viral in social communications.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Counterclockwise Program

Subjects will participate in an 6-day Counterclockwise Retreat in a retrofitted physical environment circa 1989, which helps the participant psychologically return to a time before diagnosis to re-experience their younger self. Groups will be composed of 10-12 participants plus 3 research assistants/facilitators. Participants will live during the week as if they were in 1989, talking about 1989 events as if they were in the present, and avoiding talking about post-1989 events. Everybody will be invited to participate in conversations and discussions about 1989 in the present tense (presente). Furniture, posters, music, television, newspapers, and technological instruments will all reflect what was available in 1989. Participants will be told not merely to reminisce about this earlier era, but to "inhabit" life in that era, making a psychological leap to be the person they were at the end of the 1980s.

Group Type: EXPERIMENTAL

Counterclockwise program

Intervention Type: BEHAVIORAL

A group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period.

Active control group

Participants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency).

Group Type: ACTIVE_COMPARATOR

Active control group

Intervention Type: BEHAVIORAL

Participants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency).

No-treatment control group

Non-treated participants will be assessed with the same timeline followed by the other groups. Participants will receive three coupons, for each assessment after the baseline (at T2, T3, and T4) for a two-night break in a location of their choice (among a selection of commercial services).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Counterclockwise program

A group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period.

Intervention Type: BEHAVIORAL

Active control group

Participants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 75 years or older
• Cognitively preserved, assessed with a Mini Mental State Examination (Folstein, Robins, & Helzer, 1983) score > 18
• Able to commit the time requested to join the retreat (one full week)
• Live in Milan (Italy), or close enough to travel to attend the assessments

Exclusion Criteria

• Major disability that involves the use of a wheelchair or technological devices (e.g., communication device, invasive or non-invasive ventilation)
• Recent (<9 months) traumatic events (e.g., death of a close relative, life-threatening events)
• Traumatic events toward the end of the '80s or the beginning of the '90s

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pagnini

Assistant Professor of Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università Cattolica del Sacro Cuore

Milan, MI, Italy

Countries

Italy

References

Pagnini F, Cavalera C, Volpato E, Comazzi B, Vailati Riboni F, Valota C, Bercovitz K, Molinari E, Banfi P, Phillips D, Langer E. Ageing as a mindset: a study protocol to rejuvenate older adults with a counterclockwise psychological intervention. BMJ Open. 2019 Jul 9;9(7):e030411. doi: 10.1136/bmjopen-2019-030411.

Reference Type: DERIVED

PMID: 31289097 (View on PubMed)

Other Identifiers

Ageing01

Identifier Type: -

Identifier Source: org_study_id